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Protect sites in the US will serve to provide the FDA with US-specific data on the post-market experience with the Endeavor stent. The US sites will enroll a minimum of 1,000 patients who receive Endeavor stents through Protect or, if necessary, through a nonrandomized continued-access arm.
Laura Mauri, chief scientific officer of the Harvard Clinical Research Institute in Boston, said: "This trial, including at least 1,000 in the US arm, will help further clarify the critical balance between safety and efficacy of drug-eluting stents in real-world practice."
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